Randox Laboratories

Complete recall history across all FDA and CPSC categories — 6 total recalls

Randox Laboratories appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (6)

FDA medical device enforcement actions by Randox Laboratories

Date Product Reason Class
Feb 1, 2023 CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro deter... The Antibody (R2 reagent) is showing a positive bias compared to previous bat... Class II
May 4, 2018 RX Imola (RX4900) For Professional Use for the quantitative in vitro deter... Abnormal premature termination of the software could affect the use of the an... Class II
Aug 11, 2017 Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) The ACTH in Immunoassay Premium and Premium Plus quality control does not mee... Class III
Aug 11, 2017 Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) The ACTH in Immunoassay Premium and Premium Plus quality control does not mee... Class III
Apr 27, 2017 Liquid Urine Control Level 3 For Professional Use in the quality control m... According to Randox Laboratories an investigation indicates a labelling error... Class III
Sep 16, 2016 The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid c... An internal real-time stability monitoring program revealed decreased recover... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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